510(k) K831404
K831404 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "BLOOD MONITOR BMM 10-4". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code LLB (System, Blood, Extracorporeal And Accessories), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1984
- Date Received
- May 2, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Blood, Extracorporeal And Accessories
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type